Epidural Anesthesia Kit
Anesthesiology · 21 CFR 868.5120
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Recent MDR events
1,130 adverse event reports on file
- Design Options®Jul 29, 2026MalfunctionB. Braun Medical Inc.50068559
- DESIGN OPTIONS®Jul 21, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00733
- PERIFIX®Jul 20, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00720
- PERIFIX®Jul 15, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00707
- CONTINUOUS EPIDURAL TRAYS (KITS)Jul 13, 2026InjuryB. Braun Medical Inc.MW5190618
- EPIDURAL KITJul 9, 2026InjuryUnknownMW5190563
- ARROW EPIDURAL CATHETERIZATION SET NRFITJun 24, 2026MalfunctionArrow International Llc3006425876-2026-00687
- PERIFIX®Jun 19, 2026InjuryB. Braun Medical Inc.2521402-2026-00621
- DESIGN OPTIONS®Jun 18, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00626
- MEDLINEJun 5, 2026MalfunctionProductos Medline S.a. De C.v.1417592-2026-02165
Event type breakdown
Recalls
33 recall events for this product code
- Windstone Medical Packaging, Inc.Open, ClassifiedJul 27, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Z-2813-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2263-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2266-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2268-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedMay 29, 2026
Brand Name: B. BRAUN MEDICAL INC.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2269-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedMay 28, 2026
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Z-2233-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedApr 30, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Z-2012-2026 · View FDA record ↗ - B BRAUN MEDICAL INCOpen, ClassifiedOct 9, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga.
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0114-2026 · View FDA record ↗ - B BRAUN MEDICAL INCOpen, ClassifiedOct 9, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwou
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0115-2026 · View FDA record ↗ - B BRAUN MEDICAL INCOpen, ClassifiedOct 9, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwo
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0116-2026 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Sterigenics U.s., Llc
Queensbury, NY, US
Arrow International Llc (subsidiary Of Teleflex Incorporated)
Morrisville, NC, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
B. Braun Medical Inc.
BETHLEHEM, PA, US
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Custom Interventional Pain Management
San Antonio, TX, US
Midwest Sterilization Corp.
LAREDO, TX, US
Zhejiang Runqiang Medical Instruments Co.,ltd.
Jiaxing Zhejiang, CN
Medline Industries, Lp - Spt
Waukegan, IL, US
Sterigenics U.s., Llc
Ontario, CA, US
Sterigenics U.s., Llc
Atlanta, GA, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Pajunk Medical Systems
Alpharetta, GA, US
Cardinal Health 200, Llc
El Paso, TX, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Arrow International, Llc (subsidiary Of Teleflex Incorporated)
Wyomissing, PA, US
B. Braun Us Device Manufacturing Llc
ALLENTOWN, PA, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Isomedix Operations Inc
El Paso, TX, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
B. Braun Medical Inc.
Allentown, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.